Cystic Fibrosis in ChildrenNCT06188988
Viral Infections and Airway Microbiome in Young Children With Cystic Fibrosis
An observational study of Cystic Fibrosis in Children and Respiratory Bacterial Infection, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Cystic fibrosis (CF) is the most common hereditary life-threatening condition in Belgium. Because of a dysfunctional cystic fibrosis transmembrane conductance regulator (CFTR) channel, chloride is unable to move to the cell surface and mucus becomes more viscous. Read more about this study
- Who is it for?
- Ages 0 to 5 years
- Conditions the study is for
- Cystic Fibrosis in Children, Respiratory Bacterial Infection, Respiratory Viral Infection
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2023to 19 Feb 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be recruited at the paediatric cystic fibrosis clinic of the Antwerp University Hospital. Inclusion criteria are an age of less than 5 years and a diagnosis of cystic fibrosis (confirmed by sweat chloride levels > 60 mmol/L and/or two pathogenic CFTR variants).
Who may be able to join
- Diagnosis of cystic fibrosis
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Interaction Between Viral Infections and the Development of the Airway Microbiome in Young Children With Cystic Fibrosis
Cystic fibrosis (CF) is the most common hereditary life-threatening condition in Belgium. Because of a dysfunctional cystic fibrosis transmembrane conductance regulator (CFTR) channel, chloride is unable to move to the cell surface and mucus becomes more viscous. Consequently, CF patients are not able to clear their lungs efficiently, and trapped bacteria can lead to chronic infection and inflammation of the lungs, and ultimately respiratory failure.
CF lung disease starts at birth due to muco-inflammatory processes and is associated with a significantly altered microbial colonization of the infant airways compared to infants without CF. Additionally, young children with CF suffer from viral infections as often as their healthy peers, but the episodes are more severe and often prolonged. Moreover, frequent viral infections in children with CF contribute towards a more pathogenic airway microbiome at a young age. Although this link has been previously reported, the exact mechanisms by which this occurs need to be elucidated.
Read more
A pulmonary exacerbation in CF is characterized by an increase in respiratory symptoms, general symptoms and a decline in lung function. Most young children with CF suffer from a mean of 4 exacerbations per year for which antibiotics are prescribed. Despite the current novel therapies in CF, treatment of respiratory infections stay relevant and is a greater challenge with increasing survival.
The key objective of this study is to gain insights into the mechanisms by which viral infections leading to pulmonary exacerbations induce a more pathogenic microbiome in young children with CF.
About forty participants will be recruited at the paediatric CF clinic of the Antwerp University Hospital. Inclusion criteria are an age of less than 5 years and a diagnosis of CF. There are no exclusion criteria. Duration of the study is 1 year to cover for seasonality of clinical symptoms. Study visits are scheduled at 3-month intervals corresponding with the regular follow up, or unscheduled during an acute pulmonary exacerbation. From all participants, two oropharyngeal swabs (for microbiome analysis and for immunological/mucin analysis) will be collected at set time points. For the linking of the laboratory data to the clinical characteristics, we will examine demographics, environmental exposures, and disease markers of CF. Next to the collection of the oropharyngeal swabs, a history, physical examination, and technical investigations will be performed at the study visits.
- Conditions
- Cystic Fibrosis in Children, Respiratory Bacterial Infection, Respiratory Viral Infection, Inflammation Lungs, Respiratory Morbidity
- Medical subject headings
- Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
airway microbial profiles of young cystic fibrosis patients
Metagenomic shotgun sequencing after extraction of bacterial DNA from oropharyngeal swabs
Measured: 1 year
airway inflammatory profiles of young cystic fibrosis patients
cytokine levels in oropharyngeal swabs, measured by multiplex ELISA
Measured: 1 year
Airway mucin profiles of young cystic fibrosis patients
mucin profiles in oropharyngeal samples via qRT-PCR
Measured: 1 year
Demographic data of young cystic fibrosis patients
Age (in years), CFTR genotype (description of mutation), Sex (male/female), ethnicity (hispanic or latino/not hispanic or latino), race (american indian or alaska native/asian/black or african american/native hawaiian or other pacific islander/white)
Measured: 1 year
Environmental data in young cystic fibrosis patients
Mode of birth delivery (vaginal delivery / caesarian section), birth weight (in kg), feeds in infancy (breastfeeding exclusively/breastfeeding in combination with formula/exclusively formula feeding), smoke exposure (prenatal/postnatal/ongoing), day care (Yes/No), vaccinations (according to schedule/not according to schedule), physical activity (Yes/No), parent education (mother normal or low level, father normal or low level), household income (normal/low level), postcode (number), rural living (yes/no), urban living (Yes/no), season of sampling (spring/summer/autumn/winter), type of medication (name), duration of medication (in weeks), type of antibiotics for pulmonary exacerbation (name), duration time of antibiotics for pumonary exacerbation (in weeks)
Measured: 1 year
Disease markers of young cystic fibrosis patients
RR (in /min), SpO2 ( in %), BMI (in kg/m2), temperature (in °C), rhinosinusitis (yes/no), nasal congestion (yes/no), acute otitis media (yes/no), fever (yes/no), decreased activity level (yes/no), dyspnea (Yes/no), cough (Yes/no), sputum production (yes/no), wheezing (yes/no), crackles (yes/no), differential air entry (yes/no), bronchiolitis (yes/no), pneumonia (yes/no), pulmonary exacerbation (yes/no), CFQ-R score, lung function FEV1 (Z-score), lung function LCI (Z-score), bronchiectasis on CT scan (yes/no), wall thichening on CT scan (Yes/no), mucous plugging on CT scan (yes/no), air trapping on CT scan (Yes/No), previously or new relevant (extra)pulmonary conditions/illnesses (name of diagnoses)
Measured: 1 year
Secondary outcomes (1)
Virome profiling in young cystic fibrosis patients during an acute pulmonary exacerbation
Extensive profiling of viruses in young cystic fibrosis patients after taking orpharyngeal sample during an acute pulmonary exacerbation by multiplex qPCR.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Nov 2023
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188988
- Sponsor's protocol ID
- 5812
- Status last verified
- Aug 2026
- First submitted
- 9 Nov 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interaction Between Viral Infections and the Development of the Airway Microbiome in Young Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06188988
- Acronym / sponsor ID
- 5812
- Conditions
- Cystic Fibrosis in Children, Respiratory Bacterial Infection, Respiratory Viral Infection, Inflammation Lungs, Respiratory Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cystic fibrosis (CF) is the most common hereditary life-threatening condition in Belgium. Because of a dysfunctional cystic fibrosis transmembrane conductance regulator (CFTR) channel, chloride is unable to move to the cell surface and mucus becomes more viscous. Consequently, CF patients are not able to clear their lungs efficiently, and trapped bacteria can lead to chronic infection and inflammation of the lungs, and ultimately respiratory failure.
CF lung disease starts at birth due to muco-inflammatory processes and is associated with a significantly altered microbial colonization of the infant airways compared to infants without CF. Additionally, young children with CF suffer from viral infections as often as their healthy peers, but the episodes are more severe and often prolonged. Moreover, frequent viral infections in children with CF contribute towards a more pathogenic airway microbiome at a young age. Although this link has been previously reported, the exact mechanisms by which this occurs need to be elucidated.
A pulmonary exacerbation in CF is characterized by an increase in respiratory symptoms, general symptoms and a decline in lung function. Most young children with CF suffer from a mean of 4 exacerbations per year for which antibiotics are prescribed. Despite the current novel therapies in CF, treatment of respiratory infections stay relevant and is a greater challenge with increasing survival.
The key objective of this study is to gain insights into the mechanisms by which viral infections leading to pulmonary exacerbations induce a more pathogenic microbiome in young children with CF.
About forty participants will be recruited at the paediatric CF clinic of the Antwerp University Hospital. Inclusion criteria are an age of less than 5 years and a diagnosis of CF. There are no exclusion criteria. Duration of the study is 1 year to cover for seasonality of clinical symptoms. Study visits are scheduled at 3-month intervals corresponding with the regular follow up, or unscheduled during an acute pulmonary exacerbation. From all participants, two oropharyngeal swabs (for microbiome analysis and for immunological/mucin analysis) will be collected at set time points. For the linking of the laboratory data to the clinical characteristics, we will examine demographics, environmental exposures, and disease markers of CF. Next to the collection of the oropharyngeal swabs, a history, physical examination, and technical investigations will be performed at the study visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 0 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be recruited at the paediatric cystic fibrosis clinic of the Antwerp University Hospital. Inclusion criteria are an age of less than 5 years and a diagnosis of cystic fibrosis (confirmed by sweat chloride levels > 60 mmol/L and/or two pathogenic CFTR variants).
Key inclusion criteria (1 listed)
- Diagnosis of cystic fibrosis
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
airway microbial profiles of young cystic fibrosis patients
Time frame: 1 year
Metagenomic shotgun sequencing after extraction of bacterial DNA from oropharyngeal swabs
airway inflammatory profiles of young cystic fibrosis patients
Time frame: 1 year
cytokine levels in oropharyngeal swabs, measured by multiplex ELISA
Airway mucin profiles of young cystic fibrosis patients
Time frame: 1 year
mucin profiles in oropharyngeal samples via qRT-PCR
Demographic data of young cystic fibrosis patients
Time frame: 1 year
Age (in years), CFTR genotype (description of mutation), Sex (male/female), ethnicity (hispanic or latino/not hispanic or latino), race (american indian or alaska native/asian/black or african american/native hawaiian or other pacific islander/white)
Environmental data in young cystic fibrosis patients
Time frame: 1 year
Mode of birth delivery (vaginal delivery / caesarian section), birth weight (in kg), feeds in infancy (breastfeeding exclusively/breastfeeding in combination with formula/exclusively formula feeding), smoke exposure (prenatal/postnatal/ongoing), day care (Yes/No), vaccinations (according to schedule/not according to schedule), physical activity (Yes/No), parent education (mother normal or low level, father normal or low level), household income (normal/low level), postcode (number), rural living (yes/no), urban living (Yes/no), season of sampling (spring/summer/autumn/winter), type of medication (name), duration of medication (in weeks), type of antibiotics for pulmonary exacerbation (name), duration time of antibiotics for pumonary exacerbation (in weeks)
Disease markers of young cystic fibrosis patients
Time frame: 1 year
RR (in /min), SpO2 ( in %), BMI (in kg/m2), temperature (in °C), rhinosinusitis (yes/no), nasal congestion (yes/no), acute otitis media (yes/no), fever (yes/no), decreased activity level (yes/no), dyspnea (Yes/no), cough (Yes/no), sputum production (yes/no), wheezing (yes/no), crackles (yes/no), differential air entry (yes/no), bronchiolitis (yes/no), pneumonia (yes/no), pulmonary exacerbation (yes/no), CFQ-R score, lung function FEV1 (Z-score), lung function LCI (Z-score), bronchiectasis on CT scan (yes/no), wall thichening on CT scan (Yes/no), mucous plugging on CT scan (yes/no), air trapping on CT scan (Yes/No), previously or new relevant (extra)pulmonary conditions/illnesses (name of diagnoses)
1 secondary outcome
Virome profiling in young cystic fibrosis patients during an acute pulmonary exacerbation
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis in Children and Respiratory Bacterial Infection, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
airway microbial profiles of young cystic fibrosis patients (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.